Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

This study has been withdrawn prior to enrollment.

First Received on July 16, 2007. Last Updated on July 22, 2011 History of Changes

Sponsor:	Salix Pharmaceuticals
Information provided by:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00505583

Purpose

To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.

Condition	Intervention	Phase
Methadone-maintenance Subjects	Drug: MOA-728	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Triple-Dummy, 3-Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Formulation of MOA-728 in Subjects on Stable Methadone Maintenance

Resource links provided by NLM:

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.

Study Start Date:	July 2007
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion:

Healthy men or women, aged 18 to 65 years.
History of methadone treatment for at least 1 month, at a dose >=30 and <=140 mg/day.

Exclusion:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505583

Locations

United States, Florida

Gainesville, Florida, United States, 32608

Sponsors and Collaborators

Salix Pharmaceuticals

Investigators

Study Director:

Jeff Cohn

Salix Pharmaceuticals

More Information

No publications provided

Responsible Party:	Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00505583 History of Changes
Other Study ID Numbers:	3200A3-1110
Study First Received:	July 16, 2007
Last Updated:	July 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012